In order to update the "List of Equivalence Test Comparator Drugs and Generic Drugs that Meet Bioequivalence Criteria" which was published in 2020 and to support ease of application of Equivalence Test regulations for business actors, 3 (three) lists have been prepared as follows:
LIST OF EQUIVALENCE TEST COMPARATOR DRUG REGISTERED IN INDONESIA
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 11 | Allopurinol | Tablet | 100 mg | Zyloric | DKL9932004210A1 Tanggal Terbit 21-01-2019 | GLAXO WELLCOME INDONESIA - INDONESIA | GLAXO WELLCOME INDONESIA - INDONESIA | Obat Komparator |
| 12 | Alprazolam | Kaplet | 0,25 mg | Xanax | DPI1054200604A1 Tanggal Terbit 30-10-2020 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 13 | Alprazolam | Kaplet | 0,5 mg | Xanax | DPI1054200604B1 Tanggal Terbit 30-10-2020 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 14 | Alprazolam | Kaplet | 1 mg | Xanax | DPI1054200604C1 Tanggal Terbit 30-10-2020 | PFIZER ITALIA S.R.L - ITALY | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 15 | Amiodarone | Tablet | 200 mg | Cordarone | DKL1421205810A1 Tanggal Terbit 21-10-2021 | AVENTIS PHARMA - INDONESIA | AVENTIS PHARMA - INDONESIA | Obat Komparator |
| 16 | Amlodipine Besilate | Tablet | 5 mg | Norvask | DKL9219803410A1 Tanggal Terbit 08-10-2018 | PFIZER INDONESIA - INDONESIA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 17 | Amlodipine Besilate | Tablet | 10 mg | Norvask | DKL9619803410B1 Tanggal Terbit 08-10-2018 | PFIZER INDONESIA - INDONESIA | PFIZER INDONESIA - INDONESIA | Obat Komparator |
| 18 | Amlodipine Besilate/ Valsartan | Tablet Salut Selaput | 5 mg/ 80 mg | Exforge 5/80 | DKI2197301017A1 Tanggal Terbit 09-09-2021 | SIEGFRIED BARBERA, S.L. - SPAIN | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 19 | Amlodipine Besilate/ Valsartan | Tablet Salut Selaput | 5 mg/ 160 mg | Exforge 5/160 | DKI2197301017B1 Tanggal Terbit 09-09-2021 | SIEGFRIED BARBERA, S.L. - SPAIN | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
| 20 | Amlodipine Besilate/ Valsartan | Tablet Salut Selaput | 10 mg/160 mg | Exforge 10/160 | DKI2197301017C1 Tanggal Terbit 09-09-2021 | SIEGFRIED BARBERA, S.L. - SPAIN | NOVARTIS INDONESIA - INDONESIA | Obat Komparator |
EQUIVALENCE TEST COMPARATOR DRUG LIST BASED ON SEARCH IN OTHER COUNTRIES
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 11 | Cefpodoxime | Suspensi | 100 mg/5 mL | Banadoz | USA | - | Aurobindo Pharma Ltd | - |
| 12 | Cefpodoxime | Tablet | 200 mg | Cefpdoxime Proxetil | USA; Australia | - | Sandoz Inc | - |
| 13 | Ciprofloxacin | Tablet | 500 mg | Ciprobay | Singapore | Bayer AG (Germany) dan Bayer Healthcare Manufacturing (S.r.l) Italy | Bayer South East Asia, Pte Ltd | - |
| 14 | Ciprofloxacin | Tablet | 500 mg | Ciproxin | Belgium | Bayer SA, Belgium | Bayer SA, Belgium | - |
| 15 | Ciprofloxacin | Tablet pelepasan lambat | 1000 mg | Ciprobay | Philippines | Bayer Pharma AG Germany | Bayer Co. (Malaysia) Sdn Bhd | - |
| 16 | Clonazepam | Tablet | 2 mg | Rivotril (DE, AT, NL, ES); Klonopin (US) | Germany, Austria, Netherland, Sppain | - | CHEPLAPHARM ARZNEIMITTEL GMBH | - |
| 17 | Clozapine | Tablet | 25 mg | Leponex | Philippines | Novartis Saglik, Gida Ve Tarim Urunleri, San. Ve Tic. AS, Turkey | Mylan Philippines | - |
| 18 | Colchicine | Tablet | 0,5 mg | Colchicine Teva; Colchicine Sandoz | Netherland | Teva, Nederland; Sandoz, Netherland | Teva Nederland BV; Tio Farma, Netherland | - |
| 19 | Colchicine | Tablet | 0,6 mg | Colcrys | USA | - | Takeda Pharmaceuticals USA | - |
| 20 | Daclatasvir | Tablet | 30 mg; 60 mg | Daclatasvir | - | Mylan Laboratories Ltd (only the prequalified HP015/HP016 is acceptable as reference product) Sumber: WHO Recommended Comparator Product: Medicines for Hepatitis B and C | - | - |
LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022
| No | ZAT AKTIF | BENTUK SEDIAAN | KEKUATAN | NAMA DAGANG | NIE | PRODUSEN | PENDAFTAR | STATUS |
|---|---|---|---|---|---|---|---|---|
| 91 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Bisoprolol | GKL0608513317A1 Tanggal Terbit 22-04-2022 | HEXPHARM JAYA LABORATORIES - INDONESIA | HEXPHARM JAYA LABORATORIES - INDONESIA | Obat Generik |
| 92 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Biscor | DKL0605041617A1 Tanggal Terbit 28-01-2019 | FERRON PAR PHARMACEUTICALS - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 93 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Bisoprolol Fumarate | GKL0633516517A1 Tanggal Terbit 21-03-2019 | ETERCON PHARMA - INDONESIA | NOVELL PHARMACEUTICAL LAB - INDONESIA | Obat Generik |
| 94 | Bisoprolol Fumarate | Tablet Salut Selaput | 5 mg | Opiprol 5 | DKL1718829417B1 Tanggal Terbit 23-03-2018 | OTTO PHARMACEUTICALS INDUSTRIES - INDONESIA | OTTO PHARMACEUTICAL INDUSTRIES - INDONESIA | Obat Generik |
| 95 | Candesartan Cilexetil | Tablet | 16 mg | Canderin | DKL1105045910B1 Tanggal Terbit 16-07-2021 | DEXA MEDICA - INDONESIA | DEXA MEDICA - INDONESIA | Obat Generik |
| 96 | Candesartan Cilexetil | Tablet | 16 mg | Gionix | DKL1521645010B1 Tanggal Terbit 12-04-2022 | PHAROS INDONESIA - INDONESIA | PHAROS INDONESIA - INDONESIA | Obat Generik |
| 97 | Candesartan Cilexetil | Tablet | 16 mg | Candesartan cilexetil | GKL2208520810A1 Tanggal Terbit 19-04-2022 | HEXPHARM JAYA LABORATORIES - Indonesia | HEXPHARM JAYA LABORATORIES - Indonesia | Obat Generik |
| 98 | Candesartan Cilexetil | Tablet | 16 mg | Blocand 16 | DKL1821024310B1 Tanggal Terbit 14-05-2019 | PYRIDAM FARMA TBK - Indonesia | PYRIDAM FARMA TBK - INDONESIA | Obat Generik |
| 99 | Candesartan Cilexetil | Tablet | 16 mg | Candesartan | GKL1502349710B1 Tanggal Terbit 22-03-2021 | BERNOFARM - INDONESIA | BERNOFARM - INDONESIA | Obat Generik |
| 100 | Candesartan Cilexetil | Tablet | 16 mg | Candefar 16 | DKL1731539310B1 Tanggal Terbit 29-03-2018 | PRATAPA NIRMALA - INDONESIA | PRATAPA NIRMALA - INDONESIA | Obat Generik |
